| CTRI Number |
CTRI/2021/09/037007 [Registered on: 30/09/2021] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study about the effect of eye wash with triphala water along with Mud Pack Kaphaj Abhishayand (Allergic Conjunctivitis) |
|
Scientific Title of Study
|
Study of Triphala Jala Netra Prakshalan along with Mud Pack in the management of Kaphaj Abhishayand (Allergic Conjunctivitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Payal Gourana |
| Designation |
PG Scholar |
| Affiliation |
UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur |
| Address |
PG Department of Swasthvritta and Yoga, UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166854316 |
| Fax |
|
| Email |
payalgourana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Pramod Kumar Mishra |
| Designation |
HOD |
| Affiliation |
UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur |
| Address |
PG Department of Swasthvritta and Yoga, UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001009793 |
| Fax |
|
| Email |
drpramodmishra4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Pramod Kumar Mishra |
| Designation |
HOD |
| Affiliation |
UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur |
| Address |
PG Department of Swasthvritta and Yoga, UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur
RAJASTHAN
342037
India |
| Phone |
9001009793 |
| Fax |
|
| Email |
drpramodmishra4@gmail.com |
|
|
Source of Monetary or Material Support
|
| UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur |
|
|
Primary Sponsor
|
| Name |
UCA Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Jodhpur |
| Address |
UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Jodhpur |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr Pramod Kumar Mishra |
OPD of Swasthvritta and Yoga Department, Hospital of University College of Ayurveda |
UCA, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar Jodhpur
Jodhpur
RAJASTHAN |
9001009793
drpramodmishra4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: kaphaja abhishayand, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | netraprakshalan and mudpack | (Procedure Reference: sharangdhar samhita uttarjhanda 13/20, Procedure details: One teaspoon of coarse Triphala powder, soak it in one glass of lukewarm water at night and aloow it to stay overnight in a sterile jar, and in the morning strain it with the help of filter paper to make sure that all of triphala powder removed and than patient will be advised to use this Triphala jala for netraprakshalana two times a day. Mud will be soaked in simple water or rose water and patient will be advised to use this mud pack, two times in a day after Netraprakshalan.)
(1) Medicine Name: Triphala Powder , Reference: Priya Nighantu, Route: Topical, Dosage Form: Sheeta/Hima, Dose: 5(g), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All Patients in the age group of 15 to 60 years presenting the signs and symptoms of allergic conjunctivitis and of Kaphaj Abhishayanda as mentioned in the classical text will be taken into account. |
|
| ExclusionCriteria |
| Details |
Cases complicated with super added infections and corneal ulcers. Cases complicated with trachoma. Allergic conjunctivitis with other forms of allergy like Skin rash and allergic asthama. Cases complicated with Dacyrocystitis and suffering with Cataract. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Imrovement in signs and symptoms of Patient |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of drug |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2021 |
| Date of Study Completion (India) |
15/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/11/2021 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A single arm study of Triphala Jala Netraprakshalana and mudpack will be used two times a day for 30 days to relieve the symptoms of allergic conjunctivitis i.e. Kaphaj Abhishayanda in trial cases. |